PV Focus is a registered company in France, owned and managed by Thierry Hamard. With a Pharmacist background, Thierry has over 15 years of auditing experience across a spectrum of processes related to Clinical Research throughout the world.
For the last 8 years, he has focused on Pharmacovigilance processes where he has experienced first-hand Pharmacovigilance Inspections performed by different Regulatory Authorities (FDA, MHRA).
- Pharmacy Doctorate, University of Angers, France
- Post-graduate Diploma in Quality Management, University of Angers, France
Experience in Pharmacovigilance Auditing and Inspections
Thierry has more than 8 years of Global Pharmacovigilance Auditing experience. Highlights include major corporate audits and MHRA and FDA Pharmacovigilance Inspections, widely recognized as leading Regulatory Authorities in this field.
In the first 6 years of business of PV Focus, Thierry has led nearly 100 Pharmacovigilance Audits for companies of various sizes, from small start-up companies to large Pharma companies. Most of these were affiliate audits, but it also includes audits of corporate Pharmacovigilance Departments, Service Providers and Marketing Partners.
The majority of the audits conducted by PV Focus took place in Europe, but the number of affiliates audited on other continents is growing with audits conducted in the Americas, Asia and Africa.
Thierry has a long experience of auditing Clinical Research and Pharmacovigilance processes. He started his career at Bayer Pharma in France as a Clinical Quality Assurance Specialist where he supported the ISO 9000 certification process, amongst other activities. He then joined the European group of Investigator Site Auditors at Bayer in the UK and later moved to the USA and Germany to assume the role of Head, Global System Audit Management.
Thierry is a member of the BARQA Good Pharmacovigilance Practice Committee (British Association of Research Quality Assurance). Thierry is also a member of DIA (Drug Information Association) and PIPA (Pharmaceutical Information and Pharmacovigilance Association). Thierry has made presentations related to Pharmacovigilance Auditing at a number of events in Europe and the USA.